Biotem

FDA UDI

Class II (US FDA UDI)

by Biotem Co., ltd

Identity

Trade Name: Biotem FDA UDI
Generic Name: Dental implant system FDA UDI
Device Name: BIOTEM IR ANGLED ABUTMENT 3.1(octa) Ⅹ15'(angle) FDA UDI
Model / Reference: AAIT35415 FDA UDI
Description: BIOTEM IR ANGLED ABUTMENT 3.1(octa) Ⅹ15'(angle) FDA UDI

Identifiers

Primary DI / UDI-DI: 08800036212864 FDA UDI
510(k) Number: K171185 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Dental implant system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Dental implant system

Biotem by Biotem Co., ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant system.

Healing abutment Regular — BIO CONCEPT Co., Ltd. · Class II
Ball Attachment 5 mm — NOGA MEDICAL PRODUCTS LTD · Class II
Equator Abutment, Φ 6.5mm, GH 2mm — BIO CONCEPT Co., Ltd. · Class II
Short Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Magicore — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Magicore S — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Implant Regular — BIO CONCEPT Co., Ltd. · Class II
TRI — Tri Dental Implants Int. AG · Class II

Cleared under the same submission

K171185 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biotem Co., ltd

Sources (1)

FDA UDI b4e825f6-1f64-40da-ae4d-2936da747b48 34 fields · synced May 29, 2026